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June 16, 2010
H1N1 Real Time PCR Kits Technology for Sale
PRODUCTS
Emergo Regulatory
International Regulatory Compliance Information
This is a sample web page that shows how you could display your company's international regulatory compliance information. Having a dedicated regulatory compliance page is useful to prospective customers, end users, distributors and regulatory officials. Please note that while the information you post is not confidential, it does make it more readily accessible to your competitors. Keep this in mind if there is any question regarding the classification of your devices or if you would prefer not to disclose the regulatory information that could be obtained from the documents.
Most links shown below do not function and are for illustration purposes only.
QUALITY MANAGEMENT SYSTEM
ISO 13485 quality system certification (PDF format)
ISO 13485:2003 certificate
PRODUCT CERTIFICATIONS AND APPROVALS
EUROPE - CE Marking certificates(PDF format)
Device 1 | Device 2 | Device 3 | Device 4
EUROPE - Declarations of Conformity (PDF format)
Device 1 | Device 2 | Device 3 | Device 4
INDIA -
GLOBAL REGULATORY REPRESENTATIVES
Shown below are our in-country representatives for regulatory affairs issues and incident reporting. For a list of our distributors worldwide, please click here. NOTE: Emergo is listed as the representative for all regions below. You should, of course, list the appropriate representative for your company in each region.
EUROPE - Authorized Representative
Emergo Europe, The Hague, NETHERLANDS
Telephone: +31.70.345.8570
NOTIFIED BODY / REGISTRAR / CERTIFICATION BODY
Genome Diagnostics Pvt. Ltd. maintains ISO 13485:2003 certification and is audited every year by:
AAA Auditing Services
Anytown, USA
Telephone: +1.555.555.1234
Website link
MATERIAL SAFETY DATA SHEETS
Device 1 | Device 2 | Device 3 | Device 4